Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal

NCT06213207 | Completed DMC

• 2 other identifiers: NP593-20232023-0091
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities. The investigators will assess the newborn in terms of their health outcomes. Characteristics related to the performance of skilled birth attendants will be measured prior to the intervention. After six months of the intervention, endline assessment will be conducted. The intervention unit are the health facilities which provide the services as birthing centers. The effectiveness of the intervention will be examined using generalized estimating equation against baseline vs. endline on skills performance of the health workers and newborn health outcomes. The study will be implied in the similar settings to improve the skill performance and newborn health outcomes in order to reduce neonatal mortality.

Conditions

Newborn Morbidity; Newborn Asphyxia; Delivery Preterm

Keywords

Skilled birth attendant; Management of newborn asphyxia; Neonatalie; Cluster Randomized Controlled Trial; Nepal

Outcome Measures

Primary Outcomes (1)

• Skill performance of the newborn care provider

  The skill performance of the newborn care providers covering all nine components of essential newborn care. Their skills related to resuscitation procedures will be measured using skill inventory.

  six months

Study Arms (2)

Newborn care service providers with simulation-based training and newborns

EXPERIMENTAL

Newborn care providers will be the subject for receiving intervention. The will receive 5 days training on managing essential newborn care and birth asphyxia using neonatalie. The service providers will be provided monthly mentoring and coaching. The newborn who receive the services

Other: Simulator based training to manage asphyxia and essential newborn care using neonatalie

Controlled health facilities with newborn care service providers with no training and newborns

NO INTERVENTION

The newborn care providers from control health facilities will not receive any additional training. They provide usual services.

Interventions

Simulator based training to manage asphyxia and essential newborn care using neonatalie OTHER

The intervention, HBB training package will be used which was applied to train the hospitals staff in Nepal (Chaulagain et al., 2021) and Laerdal Global Health (Laerdal Global Health, 2021) to enhance the competencies on the resuscitation to newborn using NeoNatalie. Health workers will receive 5 days simulation training by expert pediatrician and pediatric nurse who have prior working experience in Neonatal Intensive Care Unit (NICU) or Special Neonatal Care Unit. After the training, mentoring and coaching will be provided experienced newborn coach/trainer on a monthly basis for six months.

Newborn care service providers with simulation-based training and newborns

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Health service providers those are directly involved in providing newborn care services
• Have received Community-based Integrated Management of Neonatal and Childhood Illness (CB-IMNCI) training Have worked in the study facilities at least one year

You may not qualify if:

• Health workers, Those lack experience at least six months of working in birthing centers Those who does not qualify as skilled birth attendant (non-SBA) Those who received training already

Sponsors & Collaborators

• Integrated Development Foundation Nepal: lead
• Women and Children Welfare Society Nepal: collaborator

Study Sites (1)

Development and Research Service International Nepal

Lalitpur, Nepal

Location

MeSH Terms

Conditions

Asphyxia Neonatorum; Premature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Santosh Adhikari, MD

  Kanti Children's Hospital, Kathmandu

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As this is a cluster randomized controlled trial, masking is not possible. The intervention participants from intervention cluster receive intervention and control will be receiving usual services. The outcomes assessor will not be known about the name of health facilities. This is done using coding of the health facilities.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Khem Pokhrel, Principal Investigator, SaLiN Project

Model Details: The intervention is targeted to provide simulator based training to newborn care service providers. The training is comprised of essential newborn care practices and the providers will be followed up and provided mentoring and coaching for the period of six months.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 19, 2024
• Study Start: February 18, 2024
• Primary Completion: February 28, 2025
• Study Completion: December 31, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)